First-in-class CMV treatment showed better efficacy in refractory patients with genetic resistance than those without; US FDA advisory committee will separately consider benefit-risk in each type of patient. On the safety side, taste disturbance is the only adverse event that stands out.
A US Food and Drug Administration advisory committee will consider the weight of the evidence for use of Takeda Pharmaceutical Co. Ltd.’s first-in-class cytomegalovirus infection treatment mirabavir in post-transplant patients who are refractory to CMV treatment, with or without genotypic resistance.
In briefing documents released ahead of a 7 October meeting of the Antimicrobial Drugs Advisory Committee, the FDA said Takeda’s...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
